Three new trials from research institutions, including Rutgers Health, all involving patients from Robert Wood Johnson University Hospital (RWJUH), an RWJBarnabas Health facility, support the use of less invasive treatments that work for more patients with valvular disease.
All three trials demonstrated that catheter-based procedures threaded through blood vessels can match the long-term results of open-heart surgery in relatively healthy patients and offer life-saving options to people too frail for open-heart surgery.
Their rapid-fire publications also mark a major victory for Mark J. Russo, professor of surgery and chief of cardiac surgery at Rutgers Robert Wood Johnson Medical School, and chief of cardiothoracic surgery at RWJUH.
Russo’s successful trial work should help bring more upcoming trials to New Brunswick, ensuring patients with conditions that respond poorly to existing standards of care have the best possible access to experimental procedures that may work better.
It also means other patients will receive new standards of care as soon as trials validate them – and receive them from teams that already have experience providing the new procedures.
Trial results in The New England Journal of Medicine reported on 1,000 relatively healthy patients with severe symptomatic aortic stenosis who were randomly assigned to either open heart surgery or a transcatheter aortic valve replacement (TAVR) through an artery in the leg. Researchers found statistically identical results after seven years in death, stroke and rehospitalization related to the procedure, the valve or heart failure: 34.6% in the TAVR group and 37.2% in the surgery group.
The second of the three new trials, which appeared in The Lancet, tested a catheter designed specifically for leaky rather than blocked valves in 700 high-risk patients. The new device beat preset performance targets at 30 days, one year and two years. Death from any cause was 7.7% and 13.3% at two years, sharply under the prespecified 25% one-year target.
Moderate or severe leaking through the new valve was rare. Measures of heart size and function improved, and many patients reported less shortness of breath and better quality of life.
The third study, also in The Lancet, moved the catheter approach to the mitral valve, which separates the heart’s main pumping chamber from the left atrium. When the mitral valve leaks badly – a condition known as mitral regurgitation – blood sloshes backward into the lungs, and patients can become severely short of breath. Many are older and too sick for open-heart surgery. Others don’t have the right anatomy for transcatheter edge-to-edge repair, in which doctors clip the valve’s leaflets together.
The trial enrolled 299 patients who were unsuitable for traditional surgery or edge-to-edge repair and provided them with a new transcatheter mitral valve replacement system. The 30-day mortality was 0.7%, compared with an expected 6.6% surgical mortality based on risk scores. At one year, the composite of all-cause death and heart failure hospitalization was 25.2%, well below the 45% performance goal.
Russo called the device design “brilliant but a little bit complicated” and said the complexity of the procedure would probably limit it, at least initially, to academic medical centers such as RWJUH.
Russo said he sees the series as a template for how new valve technologies move from desperate cases to everyday practice. Initial TAVR studies focused on very high-risk patients with severe aortic stenosis who couldn’t safely undergo surgery. As results improved, trials moved stepwise into intermediate and low surgical risk groups, until the most recent trial could show that catheter valves and surgical valves were essentially equivalent in carefully selected low-risk patients over seven years.
A similar path may now unfold for dedicated devices in aortic regurgitation and mitral regurgitation.
